This is the third post in this series*; please see Part II for a review. Part II offered several arguments against the assertion that it is a good idea to perform efficacy trials of medical claims that have been refuted by basic science or by other, pre-trial evidence. This post will add to those arguments, continuing to identify the inadequacies of the tools of Evidence-Based Medicine (EBM) as applied to such claims.

Prof. Simon Replies

Prior to the posting of Part II, statistician Steve Simon, whose views had been the impetus for this series, posted another article on his blog, responding to Part I of this series. He agreed with some of what both Dr. Gorski and I had written:

The blog post by Dr. Atwood points out a critical distinction between “biologically implausible” and “no known mechanism of action” and I must concede this point. There are certain therapies in CAM that take the claim of biological plausibility to an extreme. It’s not as if those therapies are just implausible. It is that those therapies must posit a mechanism that “would necessarily violate scientific principles that rest on far more solid ground than any number of equivocal, bias-and-error-prone clinical trials could hope to overturn.” Examples of such therapies are homeopathy, energy medicine, chiropractic subluxations, craniosacral rhythms, and coffee enemas.

The Science Based Medicine site would argue that randomized trials for these therapies are never justified. And it bothers Dr. Atwood when a systematic review from the Cochrane Collaboration states that no conclusions can be drawn about homeopathy as a treatment for asthma because of a lack of evidence from well conducted clinical trials. There’s plenty of evidence from basic physics and chemistry that can allow you to draw strong conclusions about whether homeopathy is an effective treatment for asthma. So the Cochrane Collaboration is ignoring this evidence, and worse still, is implicitly (and sometimes explicitly) calling for more research in this area.

On the other hand:

There are a host of issues worth discussing here, but let me limit myself for now to one very basic issue. Is any research justified for a therapy like homeopathy when basic physics and chemistry will provide more than enough evidence by itself to suggest that such research is futile(?) Worse still, the randomized trial is subject to numerous biases that can lead to erroneous conclusions.

Review

This is the second post in a series* prompted by an essay by statistician Stephen Simon, who argued that Evidence-Based Medicine (EBM) is not lacking in the ways that we at Science-Based Medicine have argued. David Gorski responded here, and Prof. Simon responded to Dr. Gorski here. Between that response and the comments following Dr. Gorski’s post it became clear to me that a new round of discussion would be worth the effort.

Part I of this series provided ample evidence for EBM’s “scientific blind spot”: the EBM Levels of Evidence scheme and EBM’s most conspicuous exponents consistently fail to consider all of the evidence relevant to efficacy claims, choosing instead to rely almost exclusively on randomized, controlled trials (RCTs). The several quoted Cochrane abstracts, regarding homeopathy and Laetrile, suggest that in the EBM lexicon, “evidence” and “RCTs” are almost synonymous. Yet basic science or preliminary clinical studies provide evidence sufficient to refute some health claims (e.g., homeopathy and Laetrile), particularly those emanating from the social movement known by the euphemism “CAM.”

It’s remarkable to consider just how unremarkable that last sentence ought to be. EBM’s founders understood the proper role of the rigorous clinical trial: to be the final arbiter of any claim that had already demonstrated promise by all other criteria—basic science, animal studies, legitimate case series, small controlled trials, “expert opinion,” whatever (but not inexpert opinion). EBM’s founders knew that such pieces of evidence, promising though they may be, are insufficient because they “routinely lead to false positive conclusions about efficacy.” They must have assumed, even if they felt no need to articulate it, that claims lacking such promise were not part of the discussion. Nevertheless, the obvious point was somehow lost in the subsequent formalization of EBM methods, and seems to have been entirely forgotten just when it ought to have resurfaced: during the conception of the Center for Evidence-Based Medicine’s Introduction to Evidence-Based Complementary Medicine.

Thus, in 2000, the American Heart Journal (AHJ) could publish an unchallenged editorial arguing that Na2EDTA chelation “therapy” could not be ruled out as efficacious for atherosclerotic cardiovascular disease because it hadn’t yet been subjected to any large RCTs—never mind that there had been several small ones, and abundant additional evidence from basic science, case studies, and legal documents, all demonstrating that the treatment is both useless and dangerous. The well-powered RCT had somehow been transformed, for practical purposes, from the final arbiter of efficacy to the only arbiter. If preliminary evidence was no longer to have practical consequences, why bother with it at all? This was surely an example of what Prof. Simon calls “Poorly Implemented Evidence Based Medicine,” but one that was also implemented by the very EBM experts who ought to have recognized the fallacy.

There will be more evidence for these assertions as we proceed, but the main thrust of Part II is to begin to respond to this statement from Prof. Simon: “There is some societal value in testing therapies that are in wide use, even though there is no scientifically valid reason to believe that those therapies work.”

It was a bad week for science-based medicine. It was a good week (sort of) for science-based medcine.

First the bad.

There has been a development that anyone who supports science in medicine and opposes quackery will likely find disturbing. Do you remember Senator Tom Harkin (D-IA)? We’ve written about him extensively over the last several months on this blog. First of all, he is the man most responsible for the creation of that government-sanctioned, government-funded bastion of pseudoscience, the National Center for Complementary and Alternative Medicine. He’s also one of the men most responsible for the Dietary Supplement Health and Education Act (DSHEA) of 1994, which has done more to protect the supplement industry from making dubious health claims than any other piece of federal legislation. More recently, Harkin has made a name for himself in the health care reform debate currently ongoing by inviting advocates of “integrative” medicine (IM), which in essence integrates quackery and the pseudoscientific with scientific medicine, to Capitol Hill as a means of trying to persuade his fellow legislators to include a CAM/IM version of “wellness” care as part of any bill that might pass this fall. In essence, he is trying to hijack any health care reform bill to include government sanction of unscientific medicine. Meanwhile, he has been chastising NCCAM because it hasn’t “validated” enough “alternative medicine” for his taste. (Actually, it’s validated none, because virtually none of it is likely to be valid.)

The existence of powerful supporters of pseudoscience in the highest eschelons of government has real consequences. As I’ve described before, NCCAM, being based entirely on studying highly–even ridiculously implausible–notions about disease and how to treat it, has resulted in the infiltration of quackery into academia, where ideas once rightly dismissed as quackery are respectfully given deference and studied as though they were anything other than Tooth Fairy science, a process that Dr. R. W. Donnell has amusingly termed “quackademic medicine.” One result was the expenditure of $30 million on an unethical, poorly designed, and corrupt trial of chelation therapy for cardiovascular disease. Another result was an even more unethical trial of an even more scientifically implausible remedy for a deadly cancer. Although the fact that the trial was even done is a horror, at least last week we finally found out the results, which had been suppressed for nearly four years, namely that this protocol is not just useless, but worse than useless. It’s a Pyrrhic victory for science-based medicine and cold comfort to patients with pancreatic cancer who may have continued to use this protocol during those four years, but at least we finally know.

Let’s take a look at the study. But first, a little background.(more…)

BLOGGER’S NOTE:The incident described in this post is true, although somewhat embellished to protect the names and identities of the innocent, if you know what I mean. This conversation occurred a few years ago at a large national cancer meeting.

The question caught me by surprise.

While attending a large national cancer meeting, I was having brunch with a friend, a colleague with whom I used to work when I was doing laboratory research, someone whom I hadn’t seen in a long time. She and her husband had brought along two of their oldest and dearest friends, whom they had known for decades, as well as another of my former coworkers from my old lab. We were idly chatting away and eating, when one of the occupational hazards of being a doctor presented itself. Tthe conversation drifted to medical topics. And then it came.

Although this blog is about medicine, specifically the scientific basis of medicine and threats to the scientific basis of medicine regardless of the source, several of us also have an interest in other forms of pseudoscience and threats to other branches of science. One branch of science that is, not surprisingly, critical to medicine is the science of biology, and the organizing theory of biology is the theory of evolution, which was first reported by Charles Darwin and subsequently synthesized with the developing science of genetics in the early 20th century and then with our increasing knowledge of molecular biology, genomics, and proteonomics whose rise ushered us into the 21st century. However, the implications of evolution, namely that humans and apes both evolved from a common ancestor and that humans, for all their belief of being different and superior to animals, are in fact related to animals in the great chain of life going all the way back to single-celled organisms, does not go down well with certain religious fundamentalists, particularly Christian fundamentalists. Whereas I (and I daresay several of my cobloggers) find the interconnectedness of life, including humans, implied by Darwin’s theory to be beautiful and uplifting, many fundamentalists see it as a profound threat to their world view. Consequently, they have attacked the theory of evolution at every turn and tried to insert creationism, particularly the latest incarnation of creationism known as “intelligent design,” into science classes as an “alternative” to “Darwinism.” The manner in which they torture science, logic, and reason to try to cast doubt on a theory that is every bit as rock solid in terms of massive quantities of experimental and observational evidence to support it as any other theory in science, if not more so, is legendary and well documented at blogs such as The Panda’s Thumb and websites such as Talk Origins.

Although one day I plan on writing about how insights from evolutionary theory have led to deeper understandings of human disease and strategies to improve human health in the future, this time I want to concentrate on the similarities in techniques of spreading disinformation between creationists and purveyors of unscientific medical “treatments.” For background, first, you need to be aware of a movie that was released in April. The movie, Expelled!: No Intelligence Allowed was released. Starring Ben Stein at his most unctuous sporting a bullhorn and styling himself as a conservative, buttoned-down version of Angus Young through his choice of apparel in its promotional material, the movie’s main theme is that any academic who “questioned Darwinism” is “expelled” from academia. The basic idea is that “intelligent design” creationism is being “suppressed” by biologists who just can’t accept the thought of the existence of a “designer” (i.e., God). Indeed, the movie goes so far as to equate biologists and scientists who accept the theory of evolution as the best current explanation for the diversity of life to Hitler and the Nazis and their “suppression” of “alternatives” (word choice intentional) to “Darwinism” to Nazi and Stalinist persecution of dissidents and perceived threats to the regime. The movie even features a sequence where Ben Stein visits Dachau and Auschwitz, as though to imply that biologists are busy firing up the ovens for the Brave Maverick Scientists who “dissent from Darwin.”

These Brave Maverick Scientists are a lot like the Brave Maverick Doctors who champion unscientific medicine. After all, Kevin Trudeau has made a cottage industry and sold millions of books based on the claim that there are “natural cures” that “they” (as in doctors, pharmaceutical companies, and the government) don’t want you to know about and that as a consequence the full forces of these groups are being marshalled to “suppress” them and “persecute” the Brave Maverick Doctors who dare to question the “orthodoxy” of “allopathic medicine,” up to and including claims of “Nazi”-like suppression. (Just read those repositories of quackery NaturalNews.com and Whale.to if you don’t believe me.) For the “alternative medicine” movement, it’s all there, in websites, blogs, and books. But one thing that the movement pushing unscientific treatments has lacked, and that’s a movie to call its own, a movie to spread the same message.